The Ministry of Health is the governing body in New Zealand in charge of managing and developing the country's health system. The ministry funds, monitors, and regulates the performance of the health sector, ensuring all legislative requirements are met. Within the Ministry of Health, the New Zealand Medicine and Medical Devices Safety Authority (MEDSAFE) is the unit responsible for regulating therapeutic products in the country.
By administering the Medicines Act 1981 and Regulations 1984, Medsafe regulates medicine, medical devices, and other related products, such as food or cosmetics with therapeutic uses. The authority is thus responsible for pre-market approval and post-market surveillance, such as monitoring adverse reactions and handling complaints, as well as auditing and licensing medical manufacturers.
A list of Medsafe regulations can be found here on our website.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多为了获得澳大利亚市场准入,医疗器械和体外诊断(IVD)器械制造商需要将他们的产品列入由药品管理局(TGA)监管的澳大利亚医疗用品登记表(ARTG)。
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